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Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
somofilcon A
omafilcon A
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wears soft spherical contact lenses with a power between +6.00 to -10.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day;
  • Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses;
  • Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses;
  • Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with the study lenses or habitual correction;
  • Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye.

Exclusion Criteria:

  • Is participating in any concurrent clinical research study;
  • Has any known active* ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal communication);
  • Is aphakic;
  • Has undergone refractive error surgery;
  • Is an employee of the Centre for Contact Lens Research;
  • Has taken part in another clinical or (pharmaceutical) research study within the last 7 days.

Sites / Locations

  • Center for Contact Lens Research, University of Waterloo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

somofilcon A 1-day soft contact lenses

Arm Description

Habitual and refitted wearers of omafilcon A were refit into somofilcon A for a week

Outcomes

Primary Outcome Measures

Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A?
Investigator level of agreement using a Likert scale on refitting participants from omafilcon A to somofilcon A at Visit 1 (Strongly Agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A?
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day?
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A?
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Lens Fit - Post-blink Lens Movement
Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement.
Lens Fit - Lens Tightness
Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.
Lens Fit - Lens Deposition
Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film >75% surface.
Lens Fit - Centration
(3 point scale: optimum, decentration acceptable, decentration unacceptable)
Lens Fit - Lens Wettability
Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.
Overall Lens Fit Acceptance
Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less

Secondary Outcome Measures

Full Information

First Posted
July 18, 2017
Last Updated
August 27, 2019
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03226353
Brief Title
Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A
Official Title
Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
September 27, 2017 (Actual)
Study Completion Date
September 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear. The primary outcome variables for this study are: Investigator responses to refit questions; Lens fit.
Detailed Description
This is a prospective, single-site, dispensing, bilateral wear, open label, daily wear switch study, with the test lens (Somofilcon A) being worn for 7 (+5) days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
somofilcon A 1-day soft contact lenses
Arm Type
Experimental
Arm Description
Habitual and refitted wearers of omafilcon A were refit into somofilcon A for a week
Intervention Type
Device
Intervention Name(s)
somofilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
omafilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A?
Description
Investigator level of agreement using a Likert scale on refitting participants from omafilcon A to somofilcon A at Visit 1 (Strongly Agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Time Frame
1 week
Title
Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A?
Description
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Time Frame
1 week
Title
Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day?
Description
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Time Frame
1 week
Title
Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A?
Description
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Time Frame
1 week
Title
Lens Fit - Post-blink Lens Movement
Description
Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement.
Time Frame
Dispense and 1 Week
Title
Lens Fit - Lens Tightness
Description
Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.
Time Frame
Dispense and 1 week
Title
Lens Fit - Lens Deposition
Description
Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film >75% surface.
Time Frame
Dispense and 1 week
Title
Lens Fit - Centration
Description
(3 point scale: optimum, decentration acceptable, decentration unacceptable)
Time Frame
Dispense and 1 Week
Title
Lens Fit - Lens Wettability
Description
Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.
Time Frame
Dispense and 1 Week
Title
Overall Lens Fit Acceptance
Description
Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less
Time Frame
Dispense and 1 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears soft spherical contact lenses with a power between +6.00 to -10.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day; Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses; Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses; Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with the study lenses or habitual correction; Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye. Exclusion Criteria: Is participating in any concurrent clinical research study; Has any known active* ocular disease and/or infection; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal communication); Is aphakic; Has undergone refractive error surgery; Is an employee of the Centre for Contact Lens Research; Has taken part in another clinical or (pharmaceutical) research study within the last 7 days.
Facility Information:
Facility Name
Center for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A

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